FDAnews
www.fdanews.com/articles/91176-active-biotech-reports-data-from-prostate-cancer-study

ACTIVE BIOTECH REPORTS DATA FROM PROSTATE CANCER STUDY

March 12, 2007

Active Biotech has announced new positive clinical data from the Phase Ib study of TASQ, an oral treatment for prostate cancer.

By stepwise dose escalation, a safe dose of 1 mg/day of TASQ was achieved, which corresponds to a doubling of the previously reported maximum tolerated dose level of 0.5 mg/day.

"These new results confirm and reinforce earlier results obtained at a lower dose level. We now have a very complete data set that constitutes a solid base to move into Phase II clinical trials," Sven Andréasson, president and CEO of Active Biotech, said.

The 10-week study consists of patients with hormone-refractory prostate cancer. This is an advanced stage of prostate cancer where the tumor cells no longer respond to hormone treatment. All patients entering the study had rising serum levels of prostate specific antigen (PSA), which is a surrogate marker for tumor progression.

PSA measurements were recorded and PSA velocity (PSAV) was calculated after 28 days of treatment. Five out of six patients had a greater than 50 percent decrease in PSA velocity compared with prior treatment. Three of these five patients exhibited a decrease in absolute PSA levels.

Phase II studies are scheduled to start this year, the company said.